EP2381988B1 - Dispositif d'administration de médicaments - Google Patents
Dispositif d'administration de médicaments Download PDFInfo
- Publication number
- EP2381988B1 EP2381988B1 EP09804025.6A EP09804025A EP2381988B1 EP 2381988 B1 EP2381988 B1 EP 2381988B1 EP 09804025 A EP09804025 A EP 09804025A EP 2381988 B1 EP2381988 B1 EP 2381988B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- cap
- delivery device
- medication delivery
- housing
- locking means
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 239000003814 drug Substances 0.000 title claims description 111
- 229940079593 drug Drugs 0.000 title claims description 109
- 230000013011 mating Effects 0.000 claims description 9
- 206010011906 Death Diseases 0.000 description 16
- 230000007246 mechanism Effects 0.000 description 12
- 238000002347 injection Methods 0.000 description 8
- 239000007924 injection Substances 0.000 description 8
- 230000008901 benefit Effects 0.000 description 5
- 239000011521 glass Substances 0.000 description 4
- 230000003213 activating effect Effects 0.000 description 3
- 239000012634 fragment Substances 0.000 description 2
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 1
- 102000002265 Human Growth Hormone Human genes 0.000 description 1
- 108010000521 Human Growth Hormone Proteins 0.000 description 1
- 239000000854 Human Growth Hormone Substances 0.000 description 1
- 102000004877 Insulin Human genes 0.000 description 1
- 108090001061 Insulin Proteins 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 229960002897 heparin Drugs 0.000 description 1
- 229920000669 heparin Polymers 0.000 description 1
- 229940125396 insulin Drugs 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000003055 low molecular weight heparin Substances 0.000 description 1
- 229940127215 low-molecular weight heparin Drugs 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
- A61M5/31541—Means preventing setting of a dose beyond the amount remaining in the cartridge
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/27—General characteristics of the apparatus preventing use
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31525—Dosing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
- A61M5/3158—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by axially moving actuator operated by user, e.g. an injection button
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards
Definitions
- the invention concerns a medication delivery device comprising a cap.
- a medication delivery device may have a cap which is attachable to a distal part of a housing of the medication delivery device. Delivery means located at the distal part of the housing or a drug contained by the distal part of the housing may be protected by the cap. The cap is detached before medication delivery and attached after medication delivery.
- a medication delivery device may have lock-out features as part of a delivery mechanism, which prevents the user from trying to set or dial a dose when a predefined quantity of medication has been dispensed.
- US 2008/0108953 A1 shows a pen-type medication delivery device for injecting a substance from an ampoule inserted in the device.
- a delivery mechanism of the device comprises a rod.
- a safety lock is provided which stops the movement of the rod when the last dose has been dispensed.
- the medication delivery device can no longer be primed, which indicates to the user that the last dose has been delivered.
- WO 2007/011888 A2 relates to an auto-injection system having a vent device
- US 5,259,840 relates to a locking syringe
- US 5,484,413 relates to a disposable medical syringe with safety protection
- US 5,997,513 relates to a syringe cover cooperating with a needle cover
- US 2008/108953 A1 relates to an injection device with a variable thread guide.
- a medication delivery device comprising a housing, a cap configured to be attached to the housing and locking means configured to lock the cap.
- the cap In a first state the cap is detachable and in a second state the locking means locks the cap if the cap is attached. The cap can no longer be detached. In other words, once the cap has been attached the cap is not detachable during the second state.
- Embodiments of medication delivery devices may be used to deliver liquid or gel medications, e.g. insulin, human growth hormone, heparin, in particular low molecular weight heparin, their analogues and their derivatives.
- liquid or gel medications e.g. insulin, human growth hormone, heparin, in particular low molecular weight heparin, their analogues and their derivatives.
- One embodiment of the medication delivery device is designed as pen-type delivery device. This type of medication delivery device has an elongated housing and a detachable cap for covering the distal part of the housing containing the drug.
- the device may be configured to dispense fixed doses of the drug, in particular doses which may not be varied by the user, or variable, preferably user-settable, doses of the drug.
- the locking means may comprise a radially protruding portion.
- the locking means may be a resilient member or a resiliently mounted member.
- the locking means may be fixed to the housing or formed unitarily with the housing.
- the locking means may be shaped L-like.
- the locked cap When the user tries to detach the cap during the second state, the locked cap clearly indicates the end of life of a disposable medication delivery device.
- the cap is locked permanently.
- the locked cap and the housing encapsulate the drug at the end of life of the medication delivery device.
- end of life means that the last dose of drug has been delivered. The term is not limited to a disposable medication delivery device. If the medication delivery device is reusable "end of life" means that when the last dose has been delivered, the medication delivery device can be refilled.
- the cap of a conventional medication delivery device only having lock-out features as part of the delivery mechanism remains detachable so that in some cases remaining drug is clearly visible through a window in the housing.
- the window is often located in the distal part of the housing which can be covered by the cap.
- a benefit of the invention is that the locked cap covers a window in the distal part of the housing at the end of life of the medication delivery device. This results in preventing the user from trying to set or dial a dose when a predefined quantity of drug has been dispensed. The risk that the user may try to extricate the remaining drug at the end of life is reduced by encapsulating the cartridge with a locked cap that is not detachable.
- One embodiment of the medication delivery device is configured to deliver a multitude of doses of the drug.
- the cap is locked if the cap is attached after delivery of the last dose.
- the locked cap indicates that the medication delivery device has to be refilled.
- An embodiment of a reusable medication delivery device containing a drug-filled cartridge is refilled by removing the empty cartridge, inserting a new cartridge containing the drug and resetting the delivery mechanism.
- the locked cap may be unlocked when the cartridge is removed.
- Another embodiment of a reusable medication delivery device comprises a disposable unit which can be removed after delivering the last dose. If the cap is locked, the disposable unit including the cap which covers the disposable unit is at least partly removed.
- the medication delivery device comprises a moveable element, wherein, if the cap is attached, the locking means locks the cap when the element is positioned in a given position.
- a preferred given position is the position the element reaches when the last dose is delivered.
- the element is part of a delivery mechanism, e.g. the element is designed as a piston rod.
- the piston rod is configured to push a bung along a drug containing cartridge. The drug is expelled through a needle loacated at the distal part of the cartridge when the bung moves along the cartridge.
- One embodiment of the element is configured to move in a translational direction. Another embodiment of the element is configured to move rotationally and translate.
- Preferred embodiments of the locking means are configured to protrude from the housing when the element reaches the given position.
- One embodiment of the housing has an aperture designed such that the locking means are pushed through the aperture.
- the protruding locking means is coupled with mating means of the cap so that the cap is locked.
- the cap's mating means is formed as a recess for inserting the protruding locking means.
- Figure 1 shows an embodiment of a pen-type medication delivery device comprising a housing 1 and a cap 2.
- the housing 1 has a distal part 11 and a proximal part 12.
- the distal part 11 is configured to contain a drug.
- the distal part 11 serves as cartridge holder and is configured to contain a cartridge made of e.g. glass, the cartridge containing the drug.
- the cartridge has a distal end covered by a membrane.
- a bung 6 moveable to the distal direction is located at the proximal end of the cartridge.
- a needle unit 8 comprising a needle 9 for delivering the drug is attached to the distal end 11 of the housing. Before an injection is administered, the needle unit 8 is attached to the housing 1 so that a proximal end of the needle 9 punctures the membrane of the cartridge. The needle unit 8 can be detached after the injection has been administered.
- a delivery mechanism of the medication delivery device comprising setting means 4 and a piston rod 5 is located at least partly inside the housing 1.
- One embodiment of the delivery mechanism is designed such that a fixed dose is set and delivered.
- An alternative embodiment of the delivery mechanism is designed to adjust the dose to be set and delivered.
- the setting means 4 are located partly in the proximal part 12 of the housing. A part of the setting means 4 sticks out of the proximal end of the housing 1.
- the setting means 4 is configured to set a dose of the drug. When the setting means 4 is moved to a first direction the dose is set. When the setting means 4 is moved to a second direction the dose is delivered. In one embodiment the dose is set when the setting means is pulled to the proximal direction and the dose is delivered when the setting means is pushed to the distal direction. In another embodiment the dose is set when the setting means is rotationally moved and the dose is delivered when the setting means is moved to the distal direction.
- a piston rod 5 located inside the housing 1 can be moved from a starting position to an end position.
- the distal end of the piston rod 5 is coupled to the bung 6 so that it advances along the cartridge in the distal direction when the piston rod 5 moves to the distal direction.
- a window 7 or transparent region in the housing 1 shows the position of the bung 6, the position indicating the drug available inside the cartridge.
- the setting means 4 and the piston rod 5 are coupled.
- the piston rod 5 moves to the distal direction pushing the bung 6 along the cartridge when the setting means 4 moves to the second direction.
- the drug is expelled through the needle 9, when the bung 6 moves along the cartridge.
- the cap 2 When the medication delivery device is not in use the cap 2 is normally attached to the housing 1 so that the distal part 11 is covered.
- the attached cap 2 protects the distal part 11 of the housing containing the drug if the medication delivery device is not used.
- a snapping means (not shown) prevents that the cap 2 accidentally slides from the housing 1.
- the cap Before the injection is administered the cap is detached from the housing 1. The cap 2 is removed from the housing 1 and can be put aside during injection. After injection the cap 2 is reattached to protect the cartridge.
- the cap is detachable.
- the medication delivery device switches to a second state, wherein the cap 2 is locked when it is attached.
- the cap 2 is attached and cannot be removed any longer.
- the cap 2 is not detachable.
- the lock-out of the cap 2 prevents access to the cartridge and gives a clear indication to the user that the device is not meant to be used again.
- the lock-out of the cap 2 could be used in addition to a delivery mechanism lock-out feature or as a complete device lock-out feature in isolation.
- the cap may get lost, and if the cartridge should break, drug could leak out of the device. With the cap 2 locked onto the device prior to disposal, this minimizes the risk of broken glass or drug escaping should the cartridge break.
- the lock-out of the cap 2 prevents the user from removing the cap 2 once it has been replaced after the final dose has been delivered. Any remaining drug is encapsulated in a safe enclosure.
- this has two benefits; primarily it prevents the user from trying to access any of the remaining undispensed drug, and secondarily it minimizes the risk of glass fragments escaping should the cartridge break during disposal.
- the locked cap makes the disposable device safer in the end-of-life condition and reduces the risk of contamination from used needles.
- Figure 2 shows a detailed section of one embodiment of a pen-type medication delivery device during the first state.
- the section shows parts of the housing, the attached cap and the piston rod located inside the housing. For clarity reasons a cartridge is not shown.
- the cap 2 of the pen-type medication delivery device is attached to the housing 1 so that the distal part 11 of the housing is covered.
- the cap 2 and the housing 1 are detachably connected if the cap 2 is attached to the housing 1, as indicated by a double arrow 32.
- a detachable connection is a snap fit (not shown).
- the attached cap is at least partly rotatable. In another embodiment the position of the attached cap is fixed.
- the cap 2 comprises a recess 22 located in the inside wall of the cap 2.
- One embodiment of the recess is formed as circumferential trench or groove in the inner wall of the cap.
- One embodiment of the recess is formed as a cavity.
- the recess 22 serves as mating means as will be explained later.
- An aperture 18 is located in the distal part 11 of the housing. The position of the aperture 18 may be aligned with the position of the recess 22, if the cap 2 is attached.
- a clip 16, 17 serving as locking means is located inside the housing 1.
- the clip 16, 17 comprises a radially protruding portion.
- the clip 16, 17 may be secured against displacement with respect to the housing 1.
- the clip 16, 17 may be a resilient member or it may be resiliently mounted to the housing 1.
- the clip 16, 17 comprises a first part 16 and a second part 17.
- a proximal end of the first part 16 is connected with the housing 1, the first part 16 extending angularly to the inside wall of the housing 1.
- a second part 17 of the clip 16, 17 connected with the distal end of the first part 16 extends orthogonally or almost orthogonally, to the first part 16.
- the clip 16, 17 is configured such that the second part 17 of the clip 16, 17 extends through the aperture 18 when the first part 16 of the clip moves towards the inside wall of the housing 1.
- One embodiment of the clip 16, 17 is integrally formed with the housing 1.
- the first part 16 of the clip 16, 17 is moveable due to the flexibility of the material.
- Another embodiment of the clip 16, 17 is coupled with the housing via a hinge.
- the clip 16, 17 may be shaped L-like. However, the form of the clip 16, 17 is not limited to L-shape or hook-shape. Other embodiments of locking means configured to protrude from the housing are also suitable.
- a piston rod 5 comprising a distal part 51 and a proximal part 52 is located inside the housing 1.
- the piston rod 5 is moveable to the distal direction along the clip 16, 17 and the aperture 18 as indicated by arrow 31.
- the first part 51 of the piston rod 5 is configured such that it does not push the clip 16, 17 towards the inside wall of the housing 1 when this part moves along the first part 16 of the clip 16, 17.
- the second part 52 of the piston rod 5 serves as a last-dose-lock activating feature. It is configured such that the first part 16 of the clip 16, 17 is pushed to the inside wall of the housing 1 when this part of the piston rod 5 moves along the first part 16 of the clip 16, 17.
- the second part 52 of the piston rod 5 is formed cylindrically having a larger diameter than the cylindrically formed first part 51 of the piston rod 5.
- the second part 52 of the piston rod 5 comprises an elevation configured to push the first part 16 of the clip 16, 17.
- the piston rod 5 is formed cylindrically.
- the first part 51 of the piston rod 5 is designed such that the clip 16, 17 does not contact the piston rod 5 and is not pushed when the first part 51 of the piston rod 5 moves relative to the clip.
- the term “cylindrical” describes the basic form. Embodiments having a structured cylinder barrel with protrusions, helixes or threads are also included by the term "cylindrical".
- the clip 16, 17 is positioned in an initial position.
- the second part 17 of the clip 16, 17 does not protrude from the outer wall of the housing 1.
- the cap 2 is detachable.
- the first part 51 of the piston rod 5 is positioned adjacent to the clip 16, 17, but does not push the clip 16, 17.
- the cap 2 For injecting a dose the cap 2 is removed, then the piston rod 5 pushes the cartridge bung (not shown in Figure 2 ) into the distal direction so that the drug is delivered.
- the cap 2 can be attached after the injection.
- the piston rod 5 moves to the distal direction so that the second part 52 of the piston rod 5 moves towards the first part 16 of the clip 16, 17 and pushes the first part 16 of the clip 16, 17 towards the inner wall of the housing 1.
- the movement of the clip 16, 17 results in pushing the second part 17 of the clip 16, 17 through the aperture 18.
- the clip 16, 17 serves as locking means, which are not engaged with the cap 2 until the second part 52 of the piston rod 5 reaches its end-of-life position.
- the end-of-life position is the position of the piston rod 5 after the last dose has been delivered.
- the term "end-of-life position" is not limited to disposable medication delivery devices, but also describes the position of the piston rod 5 after the last dose has been delivered and before a reusable medication delivery device is refilled and the piston rod 5 is reset.
- the second part 52 of the piston rod 5 serves as activating means for engaging the locking means. Once the end-of-life position is reached, the activating means forces the second part 17 of the flexible clip 16, 17 through the aperture 18. In particular, the second part 17 is moved radially, in particular from the inside of the housing 1 to the outside of the housing 1. After the second part 17 of the flexible clip 16, 17 has been pushed through the aperture 18 the second part 52 can lock into the corresponding recess 22 of the cap 2 preventing the cap 2 from being removed once it has been attached.
- another axially incrementing component of the medication delivery device serves as pushing means and impacts on the locking means.
- the lock-out principle can be achieved for both translational drive mechanisms and rotational drive mechanisms.
- Figure 3 shows the section of the pen-type medication delivery device during the second state.
- the second part 52 of the piston rod 5 has reached its end-of-life position and is located such that the first part 16 of the clip 16, 17 is pushed and the second part 17 protrudes from the housing 1 (as indicated by arrow 33).
- the protruding second part 17 of the clip 16, 17 is designed such that the cap 2 slides over it during attachment.
- a distal edge 171 of the protruding part of the clip 16, 17 is formed as rounded edge.
- the cap 2 can be attached as indicated by arrow 34.
- the cap 2 can be attached by moving the cap 2 in the axial, in particular proximal, direction with respect to the housing 1 and with respect to the clip 16, 17. Due to the sloped proximal edge 21 of the cap and the rounded edge 171 of the protruding flexible clip, the cap 2 moves over the protruded locking means, bending it down so that the cap 2 slides over the locking means until the recess 22 reaches the locking means. When the recess 22 has reached the locking means, it snaps back to its protruding position and engages with the recess 22.
- the locking means and the recess are aligned such that the cap 2 is locked in its attachment position.
- the second part 17 of the clip 16, 17 engages with the recess 22 in the cap 2, the recess 22 serving as mating means.
- the recess 22 comprises an undercut 221.
- the end of the clip 16, 17 is hook-shaped, configured to engage with the undercut 221 when the user tries to move the cap 2 into the distal direction.
- a rotatably attachable cap 2 with a circumferential trench forming the mating means remains rotatable after the cap 2 has been locked, because the locking means engaged with the trench prevents distal movement of the cap 2, but does not prevent rotational movement. If the recess is formed as cavity the rotational movement is prevented when the locking means engages with the recess. In this case the cap 2 may rotate until the recess reaches the locking means.
- One embodiment of the medication delivery device comprises more than one locking means, e.g. two or three.
- One embodiment of the medication delivery device comprises a number of mating means, so that the cap 2 can be locked in different rotational positions.
- the cap 2 is permanently locked at the end of life of the pen-type medication delivery device. This feature provides additional feedback to the user that the device has reached end of life. In conjunction with this, the feature allows the device to seal unused medicament once the cap has been replaced at the end of life. A further benefit is that once sealed, the device is safe for disposal, as any cartridge breakage is prevented by the encapsulating cap; consequently, there is less risk of glass fragments escaping and reduced medicament leakage from the device should the cartridge shatter.
- the invention is not limited to a disposable medication delivery device.
- the invention could be integrated with a reuseable device such that the cap 2 would only unlock once a new cartridge has been loaded into the device and the device has been reset, so that the piston rod 5 no longer locks the cap via the locking element. It could even be part of a disposable unit of a reuseable medication delivery device, encapsulating the used cartridge for disposal.
- Figure 4 shows a detailed section of a further embodiment of a pen-type medication delivery device having a reusable or disposable cartridge holder unit.
- the housing 1 comprises a proximal part 12 containing the delivery mechanism, which includes the piston rod 5.
- the disposable unit 111 comprises a distal part 11 of the housing 1 which serves as cartridge holder for a cartridge 121 contained in the distal part of the housing.
- the disposable unit further comprises locking means 113 formed as a clip and a cap 2 covering the part of the housing 1 which contains the cartridge 121.
- a fitting 114 of the disposable unit 111 is configured to be releasably connected with the proximal part 12 of the housing 1.
- the cap 2 For delivering a dose the cap 2 is removed; then the piston rod 5 pushes the cartridge bung (not shown in Figure 4 ) into the distal direction so that the drug is delivered.
- the cap 2 can be attached after delivery.
- the disposable unit 111 is removed, the piston rod 5 is reset and a new unit is attached.
Landscapes
- Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Claims (12)
- Dispositif d'administration de médicament, comprenant :- un boîtier (1),- un capuchon (2) configuré pour être attaché au boîtier (1),- un moyen de verrouillage (16, 17) configuré pour verrouiller le capuchon (2),
dans lequel :dans un premier état, le capuchon (2) est détachable, et dans un deuxième état, le moyen de verrouillage (16, 17) verrouille le capuchon (2) si le capuchon (2) est attaché ;le dispositif d'administration de médicament est configuré pour contenir un médicament devant être administré ;le dispositif d'administration de médicament est configuré pour administrer une pluralité de doses du médicament, et, lorsque la dernière dose a été administrée, le capuchon (2) est verrouillé si le capuchon (2) est attaché, et, lorsqu'une quantité inférieure ou égale à une quantité prédéterminée du médicament est contenue dans le dispositif d'administration de médicament, le moyen de verrouillage (16, 17) verrouille le capuchon si le capuchon (2) est attaché ;le dispositif d'administration de médicament comprend en outre un élément mobile (5), le moyen de verrouillage (16, 17), si le capuchon (2) est attaché, verrouillant le capuchon (2) lorsque l'élément (5) est positionné dans une position donnée, la position donnée étant la position que l'élément (5) atteint lorsque la dernière dose est administrée ;caractérisé en ce quele boîtier (1) comprend une ouverture (18) conçue de telle sorte que le moyen de verrouillage (16, 17) soit poussé à travers l'ouverture (18), et en ce que le moyen de verrouillage est configuré pour faire saillie depuis le boîtier, lorsque l'élément (5) atteint la position donnée, le capuchon (2) comprenant un moyen d'accouplement (22) qui peut être mis en prise avec le moyen de verrouillage, et, lorsque le capuchon est attaché, le moyen de verrouillage saillant étant accouplé au moyen d'accouplement de capuchon de telle sorte que le capuchon soit verrouillé. - Dispositif d'administration de médicament selon la revendication 1,
dans lequel le capuchon (2) et le boîtier (1) sont configurés pour encapsuler le médicament lorsque le capuchon (2) est verrouillé. - Dispositif d'administration de médicament selon la revendication 1 ou 2,
dans lequel l'élément (5) peut être déplacé en translation et/ou en rotation. - Dispositif d'administration de médicament selon l'une quelconque des revendications 1 à 3, dans lequel l'élément (5) est conçu sous forme de tige de piston.
- Dispositif d'administration de médicament selon l'une quelconque des revendications 1 à 4, dans lequel le moyen de verrouillage (16, 17) est accouplé à l'élément (5) de telle sorte que le moyen de verrouillage (16, 17) fasse saillie lorsque l'élément (5) est situé dans la position donnée.
- Dispositif d'administration de médicament selon l'une quelconque des revendications 1 à 5, dans lequel le moyen de verrouillage (16, 17) est formé intégralement avec le boîtier (1).
- Dispositif d'administration de médicament selon l'une quelconque des revendications 1 à 6, dans lequel le moyen d'accouplement (22) est formé sous forme de renfoncement.
- Dispositif d'administration de médicament selon l'une quelconque des revendications 1 à 7, dans lequel le capuchon (2) est verrouillé de manière permanente dans le deuxième état si le capuchon (2) est attaché.
- Dispositif d'administration de médicament selon l'une quelconque des revendications 1 à 7, dans lequel le boîtier (1) est configuré pour contenir une cartouche remplaçable (121), et, lorsque la cartouche (121) est enlevée, le capuchon verrouillé (2) est déverrouillé.
- Dispositif d'administration de médicament selon l'une quelconque des revendications 1 à 9, dans lequel le boîtier comprend une unité jetable (111), et, si le capuchon (2) est verrouillé, l'unité jetable (111) peut être enlevée.
- Dispositif d'administration de médicament selon la revendication 10, dans lequel le capuchon (2) et l'unité jetable (111) sont configurés pour encapsuler une cartouche (121).
- Dispositif d'administration de médicament selon l'une quelconque des revendications 1 à 11, le dispositif d'administration de médicament étant sous forme de dispositif d'administration de médicament de type stylo.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP09804025.6A EP2381988B1 (fr) | 2008-12-23 | 2009-12-21 | Dispositif d'administration de médicaments |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP08022329A EP2201975A1 (fr) | 2008-12-23 | 2008-12-23 | Dispositif d'administration de médicaments |
PCT/EP2009/067609 WO2010072698A1 (fr) | 2008-12-23 | 2009-12-21 | Dispositif d'administration de medicament |
EP09804025.6A EP2381988B1 (fr) | 2008-12-23 | 2009-12-21 | Dispositif d'administration de médicaments |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2381988A1 EP2381988A1 (fr) | 2011-11-02 |
EP2381988B1 true EP2381988B1 (fr) | 2020-01-22 |
Family
ID=40475004
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP08022329A Ceased EP2201975A1 (fr) | 2008-12-23 | 2008-12-23 | Dispositif d'administration de médicaments |
EP09804025.6A Active EP2381988B1 (fr) | 2008-12-23 | 2009-12-21 | Dispositif d'administration de médicaments |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP08022329A Ceased EP2201975A1 (fr) | 2008-12-23 | 2008-12-23 | Dispositif d'administration de médicaments |
Country Status (6)
Country | Link |
---|---|
US (1) | US9566390B2 (fr) |
EP (2) | EP2201975A1 (fr) |
JP (1) | JP5677313B2 (fr) |
CA (1) | CA2747317A1 (fr) |
DK (1) | DK2381988T3 (fr) |
WO (1) | WO2010072698A1 (fr) |
Families Citing this family (23)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20110088986A1 (en) * | 2009-10-20 | 2011-04-21 | Chen Li-Li | Inflatable Furniture |
WO2012020083A1 (fr) * | 2010-08-13 | 2012-02-16 | Sanofi-Aventis Deutschland Gmbh | Élément de raccordement de réservoir de médicaments codé muni d'une charnière |
EP2468343A1 (fr) | 2010-12-21 | 2012-06-27 | Sanofi-Aventis Deutschland GmbH | Unité antérieure pour auto-injecteur |
EP2701782A1 (fr) | 2011-04-28 | 2014-03-05 | Sanofi-Aventis Deutschland GmbH | Interface d'administration comportant un élément de verrouillage |
TW201636068A (zh) * | 2015-01-13 | 2016-10-16 | 賽諾菲股份有限公司 | 藥物輸送裝置之組件 |
EP3061478A1 (fr) * | 2015-02-27 | 2016-08-31 | Sanofi-Aventis Deutschland GmbH | Dispositif d'administration de médicament et son procédé d'assemblage |
DK3995810T3 (da) | 2015-07-12 | 2024-01-29 | Patients Pending Ltd | Dæksel til et væskeleveringssystem med integreret stempelpositionsregistrering og tilsvarende fremgangsmåde |
CN108495674B (zh) | 2015-11-27 | 2022-08-26 | 赛诺菲-安万特德国有限公司 | 注射装置 |
USD819198S1 (en) | 2016-04-28 | 2018-05-29 | Amgen Inc. | Autoinjector with removable cap |
DK3600498T3 (da) | 2017-03-29 | 2021-03-15 | Shl Medical Ag | Sikkerhedsanordning og medicinsk afgivelsesindretning |
WO2019058382A1 (fr) * | 2017-09-19 | 2019-03-28 | Bharat Serums And Vaccines Ltd | Système d'injection multi-usage automatisé pour l'administration de médicaments injectables |
JP7275128B2 (ja) * | 2017-11-03 | 2023-05-17 | サノフイ | 薬物送達デバイス |
USD1010811S1 (en) | 2019-09-30 | 2024-01-09 | Amgen Inc. | Handheld drug delivery device |
USD1030041S1 (en) | 2020-01-14 | 2024-06-04 | Amgen Inc. | Handheld drug delivery device |
USD1030040S1 (en) | 2020-01-14 | 2024-06-04 | Amgen Inc. | Handheld drug delivery device |
CN111632219B (zh) * | 2020-06-05 | 2022-07-08 | 湖南朗普医学科技有限公司 | 一种痔疮治疗仪器 |
USD973866S1 (en) | 2020-11-05 | 2022-12-27 | Amgen Inc. | Handheld drug delivery device |
USD962423S1 (en) | 2020-11-05 | 2022-08-30 | Amgen Inc. | Handheld drug delivery device |
USD974547S1 (en) | 2020-11-05 | 2023-01-03 | Amgen Inc. | Handheld drug delivery device |
USD985118S1 (en) | 2021-03-10 | 2023-05-02 | Amgen Inc. | Handheld drug delivery device |
USD985116S1 (en) | 2021-03-10 | 2023-05-02 | Amgen Inc. | Handheld drug delivery device |
USD985117S1 (en) | 2021-03-10 | 2023-05-02 | Amgen Inc. | Handheld drug delivery device |
USD985119S1 (en) | 2021-03-30 | 2023-05-02 | Amgen Inc. | Handheld drug delivery device |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
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DK177187A (da) * | 1987-04-07 | 1988-10-08 | Dcp Af 1988 As | Doseringsenhed til dosering af et antal afmaalte maengder af en vaeske, saasom insulin, fra en glasampul |
US5259840A (en) * | 1991-09-03 | 1993-11-09 | Boris Craig R | Locking syringe |
US5403288A (en) * | 1992-02-13 | 1995-04-04 | Stanners; Sydney D. | Safety sleeve for dental syringe |
US5484413A (en) * | 1994-11-23 | 1996-01-16 | Alexis M. Gevorgian | Disposable medical syringe with safety protection |
US5997513A (en) * | 1995-11-22 | 1999-12-07 | Smith; Jerry A. | Syringe cover cooperating with needle cover |
US6846302B2 (en) * | 2002-12-31 | 2005-01-25 | Teva Medical Ltd. | Needle protector device |
JP5058998B2 (ja) * | 2005-07-18 | 2012-10-24 | ウェスト ファーマシューティカル サービシズ インコーポレイテッド | 通気手段を有する自動注入シリンジ |
DE102006038103B4 (de) | 2006-08-14 | 2017-02-23 | Tecpharma Licensing Ag | Injektionsvorrichtung mit variabler Gewindeführung |
-
2008
- 2008-12-23 EP EP08022329A patent/EP2201975A1/fr not_active Ceased
-
2009
- 2009-12-21 CA CA2747317A patent/CA2747317A1/fr not_active Abandoned
- 2009-12-21 JP JP2011542795A patent/JP5677313B2/ja active Active
- 2009-12-21 DK DK09804025.6T patent/DK2381988T3/da active
- 2009-12-21 WO PCT/EP2009/067609 patent/WO2010072698A1/fr active Application Filing
- 2009-12-21 EP EP09804025.6A patent/EP2381988B1/fr active Active
- 2009-12-21 US US13/139,693 patent/US9566390B2/en active Active
Non-Patent Citations (1)
Title |
---|
None * |
Also Published As
Publication number | Publication date |
---|---|
EP2381988A1 (fr) | 2011-11-02 |
WO2010072698A1 (fr) | 2010-07-01 |
US9566390B2 (en) | 2017-02-14 |
JP2012513269A (ja) | 2012-06-14 |
JP5677313B2 (ja) | 2015-02-25 |
DK2381988T3 (da) | 2020-04-20 |
US20120123347A1 (en) | 2012-05-17 |
EP2201975A1 (fr) | 2010-06-30 |
CA2747317A1 (fr) | 2010-07-01 |
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